1. Technical Field
The embodiments herein generally relate to diagnostic devices and methods, and, more particularly, to a hand-held device with reagents and methods for rendering safe-to-handle samples with infectious agents while preserving bacterial and viral signatures for immune and genetic-based detection diagnostics and forensics.
2. Description of the Related Art
The high risk associated with biological threat agents determines that any suspicious sample be handled under strict surety and safety controls and processed under high level containment in specialized laboratories. These specialized facilities are complex, very expensive to operate, and need to be staffed by personnel from an extremely limited pool of experts. In addition, safe means of transporting samples suspected of containing highly virulent agents to specialized high level containment laboratories for analysis is also expensive, requiring in many countries the custody of armed personnel. It can be estimated that several million dollars are spent annually worldwide to secure and safely transport an ever-increasing stream of suspicious biological samples which are collected in theatres of war, as well as in domestic environments.
As an example, U.S. Pat. No. 7,851,207 issued on Dec. 14, 2010, the complete disclosure of which, in its entirety, is herein incorporated by reference describes a device used to identify a variety of microbial agents simultaneously. The '207 patent is advantageous for the purposes for which it was developed. The sample agents that are tested are generally not preserved for subsequent detection, diagnostics, or forensics. Moreover, the '207 patent provides denaturation and purification steps that prevent immune-based testing. However, while the '207 patent analyses the sample using a single and specific nucleic-acid based methodology (hybridization), it does not preserve the sample for future testing. Accordingly, there remains a need for diagnostic techniques that reserve potentially dangerous samples for future immune or various nucleic acid based testing.